I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asia. I've received numerous awards including an Honorary Doctor of Science degree from the University of New Hampshire. I am also the author of "Drug Truths: Dispelling The Myths Of R&D" and the recently published Devalued And Detrusted: Can The Pharmaceutical Industry Restore Its Broken Image?" I am also a senior partner at PureTech Ventures.

A Plan For Big Pharma Involvement In Superbug R&D

In 1940, British researchers Ernest Chain and Howard Florey rediscovered the work of Alexander Fleming on the potent effects of penicillin in killing bacterial infections. While penicillin’s spectrum of activity was indeed exciting, the challenge was the production of this “miracle drug” which was notoriously unstable and difficult to isolate. As Britain was under aerial attack, making laboratory research next to impossible, Chain and Florey turned to researchers in the U.S. to help further study penicillin. It quickly became clear that penicillin was not only an important medicine but that, with the U.S. on the brink of war, its production was important in protecting the troops from life-threatening infections in the battlefield. Here is a history of what next transpired as told by Jeffrey L. Rodengen.

“Hitler’s nightly bombing raids on London precluded experiments there and the British appealed to the U.S. for help. When, in the summer of 1941, the Committee on Medical Research met in Washington, D.C, the meeting was attended by representatives from PfizerPfizer, MerckMerck, Lederle, Squibb, the U.S. Department of Agriculture, Johns Hopkins University and the National Defense Research Council. President Roosevelt asked the attendees to make the acceleration of penicillin production their highest priority. He urged companies to avoid duplication by embracing cooperation and communication, putting aside all patent issues. Adopting an all-for-one, one-for-all attitude, however, was easier said than done. In addition to urging every chemical company to join this effort, the government expected competitors like Pfizer, Merck and Squibb to share confidential information with everyone who wanted it.”

Despite the challenges, given this impending crisis, the industry responded and poured resources into finding a way to mass produce penicillin. Companies like Merck and Squibb tried to capitalize on their synthetic chemistry expertise and looked to manufacture penicillin in this fashion. Pfizer’s strength in 1941 was in fermentation based technology which it used successfully to produce a variety of chemicals such as citric acid and vitamins and so it sought to solve the problem in this way. By 1943, Pfizer made a major breakthrough using deep-tank fermentation techniques, essentially making the large scale production of penicillin possible. The U.S. government then authorized 19 companies to produce penicillin using the Pfizer process which Pfizer had agreed to share with its competitors. While a number of companies were involved, Pfizer has always been proud of the fact that it produced 90% of the penicillin that went ashore with the Allies on D-Day.

Imagine President Obama taking a page from President Roosevelt’s book and calling to Washington the heads of the major pharmaceutical companies, along with the heads of the NIH, the FDA, BARDA (Biomedical Advanced R&D Authority) , and the CDC, and ask that they work as a consortium to solve this problem. The 1941 rules that FDR set could be used: avoid duplication, embrace cooperation, put aside all patent issues, and share information. Here are a few thoughts on how this might work.

1) The NIH would direct a significant part of its infectious disease budget to understanding the biological mechanisms involved in bacterial resistance. 2) Pharma companies would be assigned to pursue different pathways to resistance uncovered by the NIH. If certain mechanisms were thought to be more critical, multiple companies could work on them. The Company’s responsibilities could be to find a compound suitable for drug development, then do the initial studies in animals and then in humans to demonstrate efficacy and safety (discovery through Phase 1). Should the drug look promising, the company would be asked to provide materials for clinical trials. 3) The NIH could then work with the FDA and CDC to design and fund key trials to demonstrate the viability of the new antibiotic. 4) The government would then fund the late stage clinical trials with technical support from pharmaceutical companies and the FDA. 5) The government can then license the drug to a manufacturer who would be willing to do so for a modest return and limited exclusivity.

Now, why in the world would Big Pharma agree to such a cockamamie plan? Well, first of all, Big Pharma is already doing things like this with neglected diseases. Support for some of the work being conducted by the Drugs for Neglected Diseases initiative is coming from Big Pharma in the form of compound screening, provision of compound libraries, and even lead optimization. In fact, every Big Pharma company is doing some research in diseases of the developing world; the work proposed here is not such a stretch from what is already happening on other fronts. Furthermore, while not a trivial expense, the costs of the research responsibilities for Big Pharma outlined above are not exorbitant. Yes, they will not get a financial return on this work. However, last year Johnson & JohnsonJohnson & Johnson received FDA approval for Sirturo, a drug to treat a resistant form of tuberculosis that can be used when all other drugs fail, but a drug for which they expect little financial return. Certainly, if Johnson & Johnson could do this, others could as well.

This proposal would also be dependent on the U.S. government providing funds to help pay for the clinical trials, either from existing budgets or from new funding. However, in return for this investment, the government will get affordable access to antibiotics that could prevent a health crisis.

I suspect that there will be a number of people who will find flaws with this plan. That’s fine. This is meant to spur discussion on coming up with a solution. I have read editorials lately, in publications as diverse the New York Times and Science, calling out the need for something to be done to avert this looming health crisis. Britain’s Prime Minister has warned that this will push medicine back into the “dark ages”. The President’s Council of Advisors on Science and Technology is looking for solutions. But I contend these efforts would be greatly enhanced with the participation of Big Pharma. It needs to get involved as occurred back in 1941. In doing so, it will help the superbug fight – and it might also help its reputation as well.

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I think it’s important to note how significant a role M&A plays in the discovery of new drug targets. Inviting the heads of major pharmaceutical companies will be helpful, but likely won’t reach those on the front lines (research labs, start-ups). Even Sirturo was developed by a past acquisition of J&J’s, Janssen.

A minor adjustment might involve inviting a selection of labs and small companies in the meeting as well. Preferably they would be chosen by an unbiased body of scientists, who base the choice solely on promising research.

Unfortunately, it took WWII to get the ball rolling in the first instance. Somehow, I see history repeating itself, albeit with an invisible enemy that only serves to delay any substantive reaction on our part, though we know he’s already at our door-step. Indeed, it is difficult to quantify in any anticipatory manner exactly how the enemy will manifest, what optimal & sustainable defenses will serve us best for a potentially drawn-out conflict, & what casualties we’ll incur. Moreover, unlike 70 or so years ago we find ourselves in an environment undergoing accelerated change & ubercompetition (e.g. lots of drugs coming off-patent => reduced profits) which makes us all the more short-sighted & short-term & chained to the bottom-line, & liable to render the charge a little too late, even misdirected. Case in point, the recently allocated $17M Longitude Prize to develop a diagnostic test for antibiotic resistant bacteria. Mere diagnosis is akin to developing a means to screen threatening fighters-planes from bombers, i.e., nice & kind of helpful, but hardly a cure to prevent the carnage.

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